Infrastructures for patient oriented clinical research and investigator-initiated clinical trials:
Funding Measures of the German Federal Ministry of Education and Research (BMBF)
Dr. Kirsten Steinhausen, Division of Health Research
Amsterdam, 15.01.2009
http://www.gesundheitsforschung-bmbf.de
AgendaThe German Funding system
The Health Research Programme
Patient oriented clinical research and clinical trials: the challenge
Funding Programmes for patient oriented clinical research
- Infrastructures: Clinical coordination Units/Clinical Trials Centers- Project funding the clinical trials programme- Others
Conclusion
Shared responsibilitiesProject and Institutional Funding
Federal Government
ResearchInstitutes
FhG90:10
HGF90:10
Universities
Federal State ResearchInstitutes
MPG50:50
WGL50:50
Federal Government:
BMBF
16 Federal States
Pro-jects
DFG60:40
AgendaThe German Funding system
The Health Research Programme
Patient oriented clinical research and clinical trials: the challenge
Funding Programmes for patient oriented clinical research
- Infrastructures: Clinical coordination Units/Clinical Trials Centers- Project funding the clinical trials programme- Others
Conclusion
BMBFFederal Ministry of
Education and Research
Medicineand Health
140 Mio. € in 2009
Biotechnology154 Mio. € in 2009
conducted and implemented by the
Federal Ministry of Education and Research
(BMBF)
Health Research Programme160 million € in 2009
Biomedicine andMolecular Medicine1120Mio. € in 2009
The Health Research Programme
• To examine the causes of diseases and to develop effective treatment
• To improve prevention and health precaution
• To contribute to a productive and affordable health care system
• To improve translational research and the transfer of research results into the health care system and the economy
• To foster the research landscape
Aims of the Programme:
Health Research Programme
„Research for the People“
medical devices
innovative drug development
innovative therapies
Private Enterprises and ScienceClinical Coordination
Units – KKS
Clinical Study Centres
Integrated Research and Treatment Centres - IFB
Health Care System Research
Effective Disease Control
core areasResearch Structures
© www.derspringendepunkt.info
public health
patient care
psychotherapy
Clinical Trialsneurological disorders
cardiovascular disorders
metabolic disorders
cancer
inflammatory disease
21
4 3
German Health Research Programme
• Identification of novel subject areas
• Uncovering subject-related deficits (i.e. infrastructure)
• Analysing gaps in health care system
• specifically-tailored instruments developed Clinical Trials
• Significance for the health care system
• Potential for scientific and technological innovations and for economic exploitation
… implementation
German Health Research Programme
AgendaThe German Funding system
The Health Research Programme
Patient oriented clinical research and clinical trials: the challenge
Funding Programmes for patient oriented clinical research
- Infrastructures: Clinical coordination Units/Clinical Trials Centers- Project funding the clinical trials programme- Others
Conclusion
Patient oriented clinical research/non commercial clinical trials
The situation ten years ago in Germany
• Low acceptance in medical faculties
• To few studies are performed and published
• Lack of infrastructures, lack of funding
• Too few young investigators
• study quality in comparison to the international standards too low
Implementation of funding instruments: project funding, funding of infrastructures
AgendaThe German Funding system
The Health Research Programme
Patient oriented clinical research and clinical trials: the challenge
Funding Programmes for patient oriented clinical research
- Infrastructures: Clinical coordination Units/Clinical Trials Centers-Project funding the clinical trials programme- Others
Conclusion
… are service units to support the development of clinical trials
Infrastructures for Clinical trials:Clinical Coordination Units - KKS
Were started in 1998: 12 “Coordinating Centers for Clinical Trials” were funded which
• establish a sustained infrastructure at university hospitals/medical faculties to conduct a clinical trial
• Improve standards
• Train physicians and nurses
• support designing and governing clinical trials
KKS (except CHIR-Net) have been funded over 10 years12 units were supported by BMBF with a total of 38 Mio. €
… is specifically tailored to support clinical scientists in surgery
Clinical Coordination UnitsCHIR-Net
• improve quality and number of clinical trials in surgery
• provide support for clinical trials intended by surgeons
• are small service units mostly appended to KKS (except one)
• develop training modules motivating surgeons to conduct clinical trials
• provide a network structure essential for knowledge exchange and patient recruitment
coordination unit (appended to SDGC) plus 5 regional centres
total funds: approx. 5 Mio. €. Initiation of funding: 2005
… aims at enhancing evidence-based medicine in children to increase safety of diagnostic and treatment schemes
Clinical Coordination UnitsPAED-Net
• intend to motivate paediatricians to conduct clinical trials
• offer support in the design, particularly in consideration of strict regulations
• are small modules appended to KKS at 6 sites
• network structure is essential for recruitment of small numbers of patients and for the transfer of expertise
coordination unit plus 6 regional modules funded with approx. 5.4 Mio. €
BMBF funds were provided from 2002 to 2008
Clinical Coordination Units - KKS
… could not solve all problems
• support limited to administrative and theoretical advice• lack of professional staff to conduct clinical trials on site
• Funding has terminated, KKS are know integral part of most university
• Sites have joint to form the KKS alliance
Funding has been a great success BUT
Clinical Trial Centres
• comprehensive concept for the establishment of study units at the clinics
• supply of staff trained on performing clinical trials
• development of comprehensive programmes for training medical staff
• interface to industry
Initial funding period of 4 years with the potential of another 4-years period6 centres granted since 2007 with a total of 24 Mio. € (First funding period)
… provide infrastructure and competence to conduct a clinical trial at the clinics
KKS Clinical Trial Center
PaedNet
ChirNet
Düsseldorf
Marburg
München
Heidelberg
Münster
Köln
Berlin
Kiel/Lübeck
Freiburg
Tübingen
Mainz
Dresden
LeipzigHalle
Hannover
Infrastructures for clinical trials
… is a joint Programme of the German Federal Government and the German Research Foundation (DFG)
Project funding: Clinical Trials Programme
• support multicentric clinical trials in academia • non-profit therapeutical studies• diagnosis/prevention
• open to any discipline
• selection is purely based on quality criteria:• innovation/originality• relevance to German Health System
annual calls since 2005, annual budget actually 30 Mio
Which types of trials are eligible in the programme?
Prospective multicentre clinical trials with patients
a) controlled interventional therapeutical trialsb) diagnostic studies (Phases II-IV according to Sackett)c) controlled interventional trials on secondary preventiond) prognostic studies
e) systematic reviews
Not: Trials where companies have direct commercial interest in the results
… aims to improve quality of academic trials according to ICH-GCP standards
Abstract Proposal
written review
Panel Meeting
Full Proposal
written review
Panel Meeting
Funding
resubmission (depending
overall mark)
resubmission (depending
overall mark)rejection
rejection
recommendation
recommendation
Clinical Trials Programme
How many trials funded so far?
1. Call 2. Call 3. Call 4. Call 5. Call
total budget 10 Mio € 20 Mio € 20 Mio € 30 Mio € 30 Mio €database entries 416 230 204 197 202
outlines 335 193 173 175 178
full proposals 42 32 41 63 (+4) 54(+3)
average budget 850.000 € 876.000 € 1.55 Mio € 1.52 Mio € 1,89 Mio €
granted 17 (41%) 18 (58%) 21 (51%) 23 (35%)
rejected 24 (59%) 13 (42%) 20 (49%) 42 (65%)
Fields of funded trials
020406080
100120140160180200
Urology
Infectio
logy
Genera
l Prac
tice
Pneumolog
y
Dentis
try/O
ral Surg
ery
Nephro
logy
Rheumato
logy
Dermato
logy
Ophthalmolo
gy
Orthope
dics
Radiol
ogy/N
uklear
medici
ne
Endocri
nology
Other
Gynae
cology
Anesth
esiolog
y
Gastro
enter
ology
Hemato
logy/Onco
logy
Pediat
rics
Cardiology/A
ngiology
Surge
ry
Neuro
logy
Psych
iatry/
Psych
osomati
cs/Psy
chology
Area
n
OutlinesFull ProposalsFunded
Accompanying Measures
InfrastructuresNational Trial Register (WHO, since 2008)
Research Networks/Consortia37 Clinical Research UnitsCompetence Networks in MedicineCancer Trials
TrainingJunior Training Academy “Clinical Trials”
Outlook and Conclusion
• The implementation of funding programmes in the field of patient oriented clinical research in Germany has improved the quality and the number of non- commercial clinical trials
BUT• There still remain further challenges
- quality, number and acceptance of patient oriented research in Germany has still to be improved, funding has to be continued- high costs due to high regulatory burden: activities at european and international level towards a risk based approach (OECD initiative) and harmonization- public funding and infrastructure especially for multinational clinical trials is needed (ECRIN)
Activities at european and international level
Thank you!
Dr. Kirsten SteinhausenBundesministerium für Bildung und ForschungKirsten.steinhausen@bmbf.bund.dewww.gesundheitsforschung-bmbf.de
Health Research Council
Medical Technology
Panel
Science Panel
extra-university research
panel
… consists of various experts to cover all aspects in health research
Health Research Council
Successrates of funded trials
0
5
10
15
20
25
30
35
40
Urology
Infectio
logy
Genera
l Prac
tice
Pneumolog
y
Dentis
try/O
ral Surg
ery
Nephro
logy
Rheumato
logy
Dermato
logy
Ophthalmolo
gy
Orthope
dics
Radiol
ogy/N
uklear
medici
ne
Endocri
nology
Other
Gynae
cology
Anesth
esiolog
y
Gastro
enter
ology
Hemato
logy/Onco
logy
Pediat
rics
Cardiology/A
ngiology
Surge
ry
Neuro
logy
Psych
iatry/
Psych
osomati
cs/Psy
chology
Area
%
Success Outline/Proposal (%)Success Outline/Funded (%)
Long-Term Studies in Health Research
• Demand for high quality population-based studies as well aspatient-based studies in many medical fields.
• Funding initiative by the German Federal Ministry for Educationand Research to support long-term prospective cohort studies.
• Announcement in April 2007
• Funding duration: up to 12 years(initial phase of 6 years)
• Financial volume: 4.5 Mio € per year(total of 27 Mio € for first 6 years)
Current Situation in Medical Faculties
Research Patient Care
… is characterised by hierarchical structures and little interaction between basic scientists, clinical researcher and attending doctors
Integrated Treatment Centres - IFB
Res
earc
hPatient C
are…improve the co-operation between scientists and clinicians and offer
novel career-options through flat hierarchies
career-options
early scientific independence
T r a n s l a t i o n
Integrated Treatment Centres - IFB
… have great potential to realise the vision of an integrated approach to patient-oriented research
• improvement of patient-oriented research– direct interaction of basic and clinical scientists– protected time for medical doctors– IFB-specific core-units
• strengthen the role of young academics– junior professorships– junior group-leaders– MD/PhD-programmes
• projects related to the IFB‘s subject area
Two calls in 2005 & 2007: 4 IFBs being funded for 5 ys. with a total of 100 Mio. €another 3 centres are expected to receive funding (approx. 60 Mio. € in total)
• Clinical Trials Programme
• Clinical Coordination Units - KKS
• Clinical Trials Centres
• Integrated Research and Treatment Centres - IFB
… aim at enhancing the bench-to-bedsite transfer of knowledge
Instruments to improve patient-oriented research
Shared responsibilitiesInstitutional Funding
Federal Government
ResearchInstitutes
FhG90:10
HGF90:10
Universities
Federal State ResearchInstitutes
MPG50:50
WGL50:50
Federal Government:
BMBF
16 Federal States
DFG60:40
Universities ...are sites of basic research and training MPG Max Planck Society for the Advancement of Science e.V. ...institutes perform basic research in all disciplines HGF Hermann von Helmholtz Association of National Research Centers ...research centers perform basic research in the public interest, especially using extensive large-scale equipment and develop new technologies WGL Wissensgemeinschaft Gottfried Wilhelm Leibniz ...institutes provide service for research, perform research in selected fields of science and are links between basic and applied research FhG Fraunhofer Gesellschaft ...institutes develop and implement new technologies by means of goal oriented basic and applied research
The German Research System Sites of Research
